The PACIFIC XTREME PTA Balloon Dilatation Catheter in 150mm, 200mm, 250mm and 300mm balloon length is intended to dilate stenoses in the femoral, popliteal, and infrapopliteal arteries.
The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, dual lumen coaxial shaft, and a distal dilatation balloon. The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.018" and with 4F and 5F introducer sheaths, depending on the diameter and balloon length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 90 and 130cm.
This document describes the 510(k) summary for the Medtronic Invatec PACIFIC XTREME™ PTA Balloon Dilatation Catheter (K103464). The acceptance criteria and the study to prove the device meets these criteria are based on non-clinical performance (bench testing) and biocompatibility testing, demonstrating substantial equivalence to predicate devices, as no clinical investigation was performed for this device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from FDA guidance/ISO standards) | Reported Device Performance (Summary of Bench Testing) |
|---|---|
| Minimum Balloon Burst Strength (RBP) | Performed and passed |
| Balloon Compliance (diameter vs pressure) | Performed and passed |
| Balloon Inflation and Deflation time | Performed and passed |
| Balloon Fatigue (repeat balloon inflations) | Performed and passed |
| Flexibility and Kink Test | Performed and passed |
| Torque Strength | Performed and passed |
| Balloon Preparation | Performed and passed |
| Guidewire Compatibility | Performed and passed |
| Coating Durability | Performed and passed |
| Coating Lubricity | Performed and passed |
| Catheter Diameter-balloon profile usable length | Performed and passed |
| Tensile Strength | Performed and passed |
| Catheter Body Burst Pressure | Performed and passed |
| Introducer Sheath Compatibility | Performed and passed |
| Biocompatibility Criteria (ISO 10993-1, G95-1, Class II Special Controls Guidance PTCA Catheters) | |
| Cytotoxicity | Performed and passed |
| Maximization Sensitization | Performed and passed |
| Intracutaneous Study | Performed and passed |
| Systemic Toxicity | Performed and passed |
| Material Mediated Pyrogen | Performed and passed |
| Hemolysis | Performed and passed |
| In Vivo Thromboresistance | Performed and passed |
| Lee White Coagulation Test | Performed and passed |
| Complement Activation | Performed and passed |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each specific bench or biocompatibility test. The document refers to "testing" being conducted and "finished PACIFIC XTREME™ PTA Balloon Catheters" being tested. Specific numbers of units tested are not provided.
- Data Provenance: The studies were conducted in vitro (bench testing) and in vivo (biocompatibility, e.g., animal studies for some tests like Thromboresistance and Intracutaneous). The country of origin is not specified but implicitly within the Medtronic Inc. testing framework. The data is prospective, generated specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the studies are focused on physical and biological properties of the device (bench and biocompatibility testing) rather than interpretation by human experts. The "ground truth" for these tests is defined by established international standards (ISO, FDA guidance) and internal Medtronic Invatec Risk Analysis criteria.
4. Adjudication method for the test set:
- Not applicable. The tests are objective measurements and assessments against predefined physical or biological endpoints, not subjective interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a medical catheter, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Bench Testing: Ground truth is established by engineering specifications, validated test methods, and compliance with relevant ISO standards (e.g., for burst pressure, flexibility, etc.) and FDA guidance documents.
- Biocompatibility Testing: Ground truth is established by the pass/fail criteria outlined in ISO 10993-1, FDA Blue Book Memorandum #G95-1, and the FDA guidance for Class II PTCA Catheters. The studies were conducted in accordance with the GLP regulations (21 CFR 58).
8. The sample size for the training set:
- Not applicable. This is a traditional medical device, not a machine learning or AI algorithm that requires a training set. The "training" for the device's design and manufacturing process would involve internal development and quality control, but this is not typically referred to as a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's design and manufacturing is derived from industry standards, engineering principles, and clinical requirements for safety and efficacy in its intended use.
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510(k) Summary
DEC 2 2 2010
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).
Applicant:
Official
| Contact Person: | Heather Morose, Associate Regulatory SpecialistMedtronic Inc.37A Cherry Hill DriveDanvers, MA 01923Tel: 978-739-3187Fax: 978-739-7380Email: heather.p.morose@medtronic.com |
|---|---|
| Alternate Contact: | Fred Boucher, Director, RA |
Medtronic, Inc. 37A Cherry Hill Drive Danvers, MA 01923 Tel: 978-739-3116 Fax: 978-739-7380 Email: fred.boucher@medtronic.com
Date Prepared: November 22, 2010
Device Information:
| Trade Name: | Medtronic Invatec PACIFIC XTREME™ PTA Balloon |
|---|---|
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Regulation Name: | Percutaneous Catheter |
| Classification: | II |
| Classification Panel: | Peripheral |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | LIT, DQY |
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Predicate Devices:
Invatec SUBMARINE PLUS PTA Balloon catheter (K042537) Invatec AMPHIRION DEEP OTW PTA Balloon Dilatation Catheter (K083919) Invatec ADMIRAL XTREME PTA Balloon Catheter (K100921)
Device Description:
The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, dual lumen coaxial shaft, and a distal dilatation balloon. The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.018" and with 4F and 5F introducer sheaths, depending on the diameter and balloon length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 90 and 130cm.
Indication for Use:
The PACIFIC XTREME PTA Balloon Dilatation Catheter in 150mm, 200mm, 250mm and 300mm balloon length is intended to dilate stenoses in the femoral, popliteal, and infrapopliteal arteries.
Technological Characteristics:
The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter. The catheter is compatible with .018" guidewire. The technological characteristics of the PACIFIC XTREME™ PTA Balloon Dilatation Catheter are substantially equivalent to those of the Submarine Plus PTA Balloon catheter (K042537), Amphirion Deep PTA Balloon Catheter (K083919), and the Admiral Xtreme PTA Balloon Catheter (K100921).
Summary of Bench Testing:
In vitro bench testing of the PACIFIC XTREME™ PTA Balloon Dilatation Catheter was conducted in accordance with Medtronic Invatec Risk Analysis and all applicable FDA guidance documents and ISO standards, testing included:
- Minimum Balloon Burst Strength (RBP) .
- Balloon Compliance (diameter vs pressure) .
- Balloon Inflation and Deflation time .
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- . Balloon Fatigue (repeat balloon inflations)
- Flexibility and Kink Test �
- Torque Strength .
- Balloon Preparation ●
- Guidewire Compatibility .
- . Coating Durability
- . Coating Lubricity
- Catheter Diameter-balloon profile usable length .
- Tensile Strength .
- Catheter Body Burst Pressure 0
- Introducer Sheath Compatibility 0
Summary of Biocompatibility Testing:
The PACIFIC XTREMETM PTA Balloon Dilatation Catheter is an externally communicating device, which contacts circulating blood for the limited contact duration (<24hours).
Biocompatibility testing was conducted on finished PACIFIC XTREME™ PTA Balloon Catheters in accordance with ISO 10993-1 , "Biological Evaluation of Medical Devices part 1:Evaluation and testing," as specified in the FDA Blue Book Memorandum #G95-1 and FDA guidance: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (May 30 2008) All testing documented below was conducted in accordance with the provisions of the FDA GLP regulations 21 CFR 58.
The following Biocompatibility tests were completed and passed:
- Cytotoxicity Study .
- Maximisation Sensitization Study .
- Intracutaneous Study .
- Systemic Toxicity Study .
- Material Mediated Pyrogen Study .
- Hemolysis Study .
- In Vivo Thromboresistance Study .
- Lee White Coagulation Test ●
- Complement Activation .
Medtronic PACIFIC XTREME™ Special 510(k)
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Assessment of non-clinical performance data for equivalence:
Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the PACIFIC XTREME™ PTA Balloon Dilatation Catheter acceptance criteria and performed equally to the predicate devices. No new safety or effectiveness issues were raised during the testing.
Summary of Clinical Data:
No clinical investigation has been performed for this device.
Conclusion from Data:
Medtronic Invatec has demonstrated that the PACIFIC XTREME™ PTA Balloon Dilatation Catheter is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology. Testing demonstrates that the PACIFIC XTREMETM PTA Balloon Dilatation Catheter device is safe, effective and performs as well as the predicate devices
Medtronic PACIFIC XTREME™ Special 510(k)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic, Inc. C/O Heather Morose Associate Regulatory Specialist 37A Cherry Hill Drive Danvers, MA 01923
DEC 2 2 2010
Re: K103464
Trade/Device Name: PACIFIC XTREME™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II · Product Code: LIT, DQY Dated: November 22, 2010 Received: November 24, 2010
Dear Ms. Morose:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Heather Morose
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
DEC 2 2 2010
510(k) Number (if known): Device Name: PACIFIC XTREMETM PTA Balloon Dilatation Catheter Indications for Use: The PACIFIC XTREME PTA Balloon Dilatation Catheter in 150mm, 200mm, 250mm and 300mm balloon length is intended to dilate stenoses in the femoral, popliteal, and infrapopliteal arteries.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.D.
510(k) Number K103464
Medtronic PACIFIC XTREME™ Special 510(k)
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).